Polycore Optical Pte Ltd
⚠️ Moderate Risk
FEI: 1000176103 • Singapore • SINGAPORE
FEI Number
1000176103
Location
Singapore
Country
SINGAPOREAddress
12, Kallang Sector, , Singapore, , Singapore
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/26/2005 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Polycore Optical Pte Ltd's FDA import refusal history?
Polycore Optical Pte Ltd (FEI: 1000176103) has 1 FDA import refusal record(s) in our database, spanning from 7/26/2005 to 7/26/2005.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Polycore Optical Pte Ltd's FEI number is 1000176103.
What types of violations has Polycore Optical Pte Ltd received?
Polycore Optical Pte Ltd has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Polycore Optical Pte Ltd come from?
All FDA import refusal data for Polycore Optical Pte Ltd is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.